510(k) K011233 ยท CGA Glucose Oxidase, Glucose
MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100
| Applicant | Apex BioTechnology Corp., Edina MN, US |
| Decision | Substantially Equivalent, May 18, 2001 |
| Received | Apr 23, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011233
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2008 | ARKRAY USA INC. Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution Range (mg/dL). Manufactured for Hypoguard, Minneapolis, MN 55439 USA. Made in Taiwan. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.